CataractNCT05901597
Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs
An observational study of Cataract, run by Valley Laser Eye Centre at 1 site in Canada.
Trial summary
The objective is to assess refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- 9 May 2023to 2 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects presenting with age-related cataracts (or refractive lens exchange), and a motivation for spectacle independence.
Who may be able to join
- Subjects are eligible for the study if they meet the following criteria:
- Note: Ocular criteria must be met in both eyes.
- Age-related cataract surgery (or RLE) patients that select Clareon PanOptix or AcrySof Vivity IOL.
- Gender: Males and Females.
- Age: 45 or older.
- Patients motivated to increase spectacle independence with relatively low incidence of visual phenomena.
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- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and other study procedures.
- Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error).
Who cannot join
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Ocular comorbidity (any previous ocular surgery, any signs of retinal disease, or glaucoma etc.) that might hamper post-operative visual acuity.
- Irregular corneal astigmatism and keratoconus.
- Post refractive eyes (i.e. LASIK or PRK or SMILE).
- Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
- Angle Kappa/chord mu ≥0.6.
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- Higher order corneal aberrations: > 0.6 total RMS, >0.3 coma, >0.3 trefoil (to exclude irregular corneas).
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Valley Laser Eye Centre
Abbotsford British Columbia, British Columbia
About this study
The objective is to assess refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation.
Read the detailed description
This study is a single-arm, observational study of refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation. Subjects will be assessed at preoperatively, operatively, and 10 weeks post-operatively. Clinical evaluations will include measurement of monocular and binocular visual acuity, manifest refraction, and questionnaires will also be administered.
- Conditions
- Cataract
- Being tested
- Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometerDevice
Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular refractive target accuracy
Percentage of subjects within predicted postoperative spherical equivalent of ± 0.5 D.
Measured: 10 Weeks postoperative
Secondary outcomes (7)
Prediction error
Percentage of eyes within prediction errors (PE) of ± 0.25D, 0.75D, 1.0D
Measured: 10 Weeks postoperative
Mean absolute prediction error
Measured: 10 Weeks postoperative
Median absolute prediction error
Measured: 10 Weeks postoperative
Uncorrected monocular visual acuity
at distance (6m), intermediate (60cm), and near (40cm)
Measured: 10 Weeks postoperative
Distance corrected monocular visual acuity
at distance (6m), intermediate (60cm), and near (40cm)
Measured: 10 Weeks postoperative
Manifest refraction
Measured: 10 Weeks postoperative
Back-calculated Residual Astigmatism (BRA)
using preoperative cylinder power (for toric IOLs)
Measured: 10 Weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start9 May 2023
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valley Laser Eye Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- John Blaylock, MD, Principal investigator, Valley Laser Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901597
- Sponsor's protocol ID
- JB-23-01
- Status last verified
- Feb 2026
- First submitted
- 2 Jun 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs
- ClinicalTrials.gov ID
- NCT05901597
- Acronym / sponsor ID
- JB-23-01
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Valley Laser Eye CentreUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 9 May 2023 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to assess refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation.
Detailed description
This study is a single-arm, observational study of refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation. Subjects will be assessed at preoperatively, operatively, and 10 weeks post-operatively. Clinical evaluations will include measurement of monocular and binocular visual acuity, manifest refraction, and questionnaires will also be administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting with age-related cataracts (or refractive lens exchange), and a motivation for spectacle independence.
Key inclusion criteria (9 listed)
- Note: Ocular criteria must be met in both eyes.
- Age-related cataract surgery (or RLE) patients that select Clareon PanOptix or AcrySof Vivity IOL.
- Gender: Males and Females.
- Age: 45 or older.
- Patients motivated to increase spectacle independence with relatively low incidence of visual phenomena.
Key exclusion criteria (9 listed)
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Ocular comorbidity (any previous ocular surgery, any signs of retinal disease, or glaucoma etc.) that might hamper post-operative visual acuity.
- Irregular corneal astigmatism and keratoconus.
- Post refractive eyes (i.e. LASIK or PRK or SMILE).
- Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometerClareon PanOptix and AcrySof Vivity IOL implantation Alcon Vision Suite and Argos biometer | Device | – |
Primary outcome
Monocular refractive target accuracy
Time frame: 10 Weeks postoperative
Percentage of subjects within predicted postoperative spherical equivalent of ± 0.5 D.
7 secondary outcomes
Prediction error
Time frame: 10 Weeks postoperative
Mean absolute prediction error
Time frame: 10 Weeks postoperative
Median absolute prediction error
Time frame: 10 Weeks postoperative
Uncorrected monocular visual acuity
Time frame: 10 Weeks postoperative
Distance corrected monocular visual acuity
Time frame: 10 Weeks postoperative
Manifest refraction
Time frame: 10 Weeks postoperative
Back-calculated Residual Astigmatism (BRA)
Time frame: 10 Weeks postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Blaylock, MD principal investigator
Valley Laser Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Valley Laser Eye Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocular refractive target accuracy (time frame: 10 Weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.